Dexmedetomidine or Hyalase : Which of Them Can Augment Lumbar Epidural Steroid Injection in Failed Back Surgery Patients. A Randomized Clinical Trial

Minia University

Status and phase: Completed; Early Phase 1

Conditions: Pain, Chronic

Treatments: Drug: Hylase versus dexmedtemodine

Study type: Interventional

Funder types: Other

Identifiers

NCT05370963

278/5-2022

Details and patient eligibility

About

hyalase and dexmedtemodine are well known adjuvants given epidurally to alleviate chronic back pain. Use in failed back surgery is an up to date field to hasten analgesia and py off recurrence .

Enrollment: 100 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age group. 25-75ys old
• Both sex.
• persistent (at least 6 month) pain and or disability following laminectomy with or without sensory-motor neurological deficits or any form of urinary or bowel incontinence
• Patients suffering from persistent (> 6 months) back pain following laminectomy for spinal canal stenosis and/or discectomy for herniated nucleus pulposus documented by magnetic resonance imaging (MRI) were included for screening and enrollment.

Exclusion criteria

• Diabetic patients.
• Refusal to participate
• MRI with disc sequestration, concurrent sacro-ilitis, facet arthropathy .
• Coagulopathic patients
• Surgical induced discitis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

hyalase group

Active Comparator group

Description:

Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Hyaluronidase 1,500 IU reconstituted in 1 mL distilled water (HYL)

Treatment:

Drug: Hylase versus dexmedtemodine

dexmedtemodine group

Active Comparator group

Description:

Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Dexmedetomidine 0.5 mic/kg

Treatment:

Drug: Hylase versus dexmedtemodine